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NCT Number: NCT07072676

The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period.

The planned project is an intervention study to assess the risk of falling after adaptation of an assistive gait devices in patients with the following neuromuscular diseases: Inclusion body myositis, myotonic dystrophy, limb girdle and facioscapulohumeral muscular dystrophies, Pompe disease, Lambert-Eaton syndrome, myasthenia gravis, spinal muscular atrophy, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, Friedreich's ataxia and hereditary motor and sensory neuropathy.

The primary aim is to assess the risk of falling after a suitable assistive gait device has been provided with an adaptation phase through training. The data should help to improve the provision of aids for patients with neuromuscular diseases. This should have a positive effect on the risk of falling and thus improve quality of life and reduce mortality and morbidity. To achieve these goals, a one-week intervention with training sessions on handling, balance and coordination as well as fall prevention will becarried out after the patient has been fitted with a suitable assistive gait device.

The interventions will be embedded in the inpatient rehabilitation programme. The functional gait and balance tests 'Timed Up and Go', '10 metre walk test', '6-minute walk test' and 'Dynamic Gait Index' will be recorded additionally.

The Falls Efficacy Scale International questionnaire will be utilised to evaluate the risk of falling, while the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire will be employed to ascertain satisfaction with the assistive devices. The study is scheduled to run for a period of 14 days, during which participants will undergo three functional walking and balance tests. As part of the inpatient rehabilitation programme, participants will undergo a week-long period of rehabilitation without assistive technology, followed by a subsequent week of rehabilitation with adapted assistive technology.

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Key information

Conditions

Inclusion Body Myositis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Carbohydrate Metabolism, Inborn Errors Central Nervous System Diseases Cerebellar Diseases Chronic Disease Chronic Inflammatory Demyelinating Polyneuropathy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Diseases Disease Attributes Facio-Scapulo-Humeral Dystrophy Friedreich Ataxia Genetic Diseases, Inborn Glycogen Storage Disease Glycogen Storage Disease Type II Guillain Barré Syndrome Guillain-Barre Syndrome Hereditary Motor and Sensory Neuropathies Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Immune System Diseases Lambert Eaton (LEMS) Lambert-Eaton Myasthenic Syndrome Limb Girdle Muscular Dystrophies Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Motor Neuron Disease Muscular Atrophy, Spinal Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophies, Limb-Girdle Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Myasthaenia Gravis Myasthenia Gravis Myositis Myositis, Inclusion Body Myotonic Disorders Myotonic Dystrophy Myotonic Dystrophy 1 Myotonic Dystrophy 2 Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Nutritional and Metabolic Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Pompe Disease (Infantile-Onset) Post-Infectious Disorders Spinal Cord Diseases Spinal Muscular Atrophy (SMA) Spinocerebellar Degenerations

Age range

65 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Park, Bad Feilnbach, Reithofpark

Bad Feilnbach, 53075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The Patients with sufficient cognitive and communicative abilities,
  • The Patients with confirmed by the genetic report and/or the final clinical diagnosis.

Exclusion criteria

  • The Patients scored more than 23 points on the falls efficacy Scale-International
  • The Patients are unable to walk at least ten metres without assistance,
  • The patient had knee, hip or back surgery in the last three months.
  • Patients suffering from polyneuropathy without a diagnosis of inflammatory autoimmune neuropathy.

Treatment and study plan

Assistive gait devices combined with physiotherapy

Device

During the intervenation week, the patient undergoes 12 hours/week of gait training, fall prevention, balance group and physiotherapy as part of their inpatient rehabilitation programme. The individual sessions last 30 minutes each.

Primary outcomes

  1. 6 Minute Walk Test

    Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

    The aim of this test is to walk as far as possible for 6 minutes.

  2. Timed Up and Go (TUG)

    Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

    The TUG test measures the time it takes to stand up from a chair, walk three metres, turn around and sit back down on the same chair.

  3. 10 meter walk test

    Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

    Walking at maximum speed is measured in a long, flat-surface corridor of 10 meters, with a standing start and a "flying" finish 2.5 meters beyond the 10-meter mark.

  4. Dynamic Gait Index

    Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

    Dynamic Gait Index tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls.

Secondary outcomes

  1. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

    Time frame: At the end of post-intervention period, Day 14.

    The QUEST 2.0 evaluates a patient's satisfaction with various assistive technologies.

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Acronym: Risk of fall

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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